OTTAWA, Jan. 21, 2013 /CNW/ - In order to help prevent medication errors
with the use of botulinum toxin products currently available on the
Canadian market, Health Canada will be requesting that all
manufacturers of these products revise their product labels to reflect
that each product has its own individual potency and as such, is not
interchangeable with other botulinum products.
The labelling changes are due to a risk evaluation of the active
ingredients (Clostridium botulinum toxin type A and type B) within
these products. Botulinum toxins are produced by different
manufacturing processes, are obtained by different techniques and are
derived from different Clostridium strains. As a result of these
differences, these products cannot be interchanged as these changes can
cause unexpected side-effects.
Advice to health care practitioners:
The established drug names of the botulinum products have not been
changed yet to emphasize the differing dose-to-potency ratios of these
The following products will be impacted by labelling changes (see
Manufacturers will have one year to comply with the labelling change
Continue reporting any side-effects from the use of botulinum toxin
products to MedEffect: Call toll-free at 1-866-234-2345, visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online,
by mail or by fax.
New Non-Proprietary Name
Botox / Botox Cosmetic
Xeomin / Xeomin Cosmetic
Advice to Canadians:
All botulinum toxin products have usage information in the consumer
section of the Product Monograph. Review it carefully with your health
Discuss any concerns you may have about the risks and benefits of
botulinum products with your health care practitioner.
Pay close attention for any signs or symptoms of adverse events and seek
immediate medical attention if you have unexpected difficulty
swallowing or talking, trouble breathing, or muscle weakness following
treatment with a botulinum toxin product.
Botox is indicated for the treatment of severe muscle spasm in the neck,
eye and foot, for chronic migraines, incontinence, and for excessive
sweating. Botox Cosmetic is indicated for cosmetic purposes, to treat
Dysport is indicated for the temporary improvement in the appearance of
moderate to severe wrinkles in adult patients less than 65 years of
Xeomin is indicated for severe muscle spasm in the neck, eye and arm.
Xeomin Cosmetic is indicated for the temporary improvement of moderate
to severe frown lines in adult patients.
Myobloc is indicated for the treatment of adult patients with severe
muscle spasm in the neck.
SOURCE: Health Canada
For further information:
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